Cretostimogene Grenadenorepvec Boosts Complete Response Rates, Lessens Progression of NMIBC

The oncolytic immunotherapy drug cretostimogene grenadenorepvec has demonstrated groundbreaking results for the treatment of high-risk (HR) Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) based on new topline data from the phase III BOND-003 trial.

CG Oncology has reported that 82 of 110 patients (74.5%) involved in the trial met the primary endpoint of complete response at any time after receiving single agent cretostimogene. At 12 months, 97.3% of patients were free from progression to MIBC. At 12 and 24 months or greater, a total of 63.5% and 56.6% of patients remained in response, respectively.

While the median duration of response has not yet been reached, it exceeds 27 months as of the data cutoff of September 30, 2024. No deaths or treatment-related adverse events (TRAEs) of grade 3 or higher were reported, and no treatment-related discontinuation was observed. The most common TRAEs (≥10%) included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.

Patient adherence and compliance was favorable, with 97.3% of patients completing all expected treatments.

“There continues to be a significant need for new treatment options for patients with bladder cancer,” remarked Gary D. Steinberg, MD, Department of Urology at Rush University Medical Center. “Therefore, I am very encouraged by the latest data from the BOND-003 study, which demonstrates cretostimogene’s compelling efficacy as well as its potential to induce a best-in-class durable response in NMIBC patients.”

Cretostimogene monotherapy received Fast Track and Breakthrough Therapy designations by the US Food and Drug Administration for patients with BCG-unresponsive, HR NMIBC in December 2023. If approved, cretostimogene grenadenorepvec could potentially become a new backbone treatment for NMIBC.